Kornimate/medical-research-clean huggingface dataset:
effect of artificial tears on radioiodine levels in the nasolacrimal duct system

Conditions: Thyroid Carcinoma; Radioactive Iodine Level

Summary: the purpose of this study is to explore whether administration of preservative free artificial tears will decrease the level of detectable radioiodine in the tears and nasolacrimal duct system of patients undergoing radioiodine therapy for thyroid carcinoma and thus decrease the risk of developing radioactive iodine associated nasolacrimal duct obstruction.

primary objective: - to assess whether use of preservative free artificial tears following radioactive iodine administration will lower the level of radioactive iodine in the tears of patients treated with radioactive iodine for thyroid carcinoma. secondary objective: - to evaluate whether artificial tears would be an effective preventative intervention to decrease the risk of developing nasolacrimal duct stenosis, which has been associated with radioactive iodine administration.

Eligibility criteria:
inclusion criteria: * radio-iodine therapy for thyroid cancer * radioiodine therapy ≥100mci * patient wears soft contacts on both eyes exclusion criteria: * use of eye drops, other than artificial tears * history of periocular trauma with tear duct involvement/lacrimal gland trauma * history of lacrimal drainage disease: canaliculitis, dacryocystitis * prior radiotherapy * current or prior use of chemotherapy drugs (i.e. 5-fluorouracil, docetaxel) * medical conditions that predispose to nld stenosis * sarcoid * granulomatosis with polyangiitis * chronic lymphocytic leukemia
evaluating new surgical technique in management of female patients with operable multifocal breast cancer

Conditions: Breast Cancer

Summary: multi-focal breast cancers(mfbc) still have undiscoverable clinical significance reflecting on a debatable surgical decision for this category of breast cancer. a prospective study was conducted using certain surgical technique as a surgical treatment for female patients with operable breast cancer managed at the surgical oncology unit, alexandria university from may. 2017 to may2018 and will be followed for 3 years.analysis will be done to settle a paradigm for surgical management of multi-focal breast cancer

* age at diagnosis: young patients are defined as younger than 35 years. * surgical techniques: preoperatively all patients will undergo physical examination of both breasts and axillae as well as bilateral mammograms and ultrasonography of both breasts. histopathological diagnosis of cancer will be made prior to surgery. the planned procedure will be discussed. different oncoplastic techniques will be utilized to achieve oncologically appropriate margins with either sentinel lymph node detection or axillary lymph node dissection according to the triple assessment of the patients . surgical margins were determined by macroscopic and histologic examination of frozen sections of the breast specimens in the operating room. an adequate safety margin of 1cm was always insured. breast remodeling will be done according to breast size, degree of ptosis and size of defect. * tumor characteristics: size, nodal status, presence of lympho-vascular invasion, amount of intraductal component, tumor grade, margin status, hormone receptor, and her2 neu status. * margins will be regarded as negative when permanent histological examination found no ink on the tumor. * postoperative surgical complications will be documented if happened; seroma formation, hematoma and or wound dehiscence. * cosmetic outcome: the postoperative esthetic result will be evaluated asking the patients to rate the postoperative cosmetic result and their degree of satisfaction compared to the preoperative breast using a five-point scale (excellent, 5; good, 4; fair, 3; poor, 2;bad, 1). objective assessment of the cosmetic result was done by two surgeons, rated on a visual analog scale from 1 (unacceptable result) to 10 (excellent result). evaluation is based on 5 criteria, namely: breast symmetry, glandular tissue defects, nipple and areola reconstruction, scar quality and/or retraction, and the resultant breast shape. (14) * the occurrence of loco-regional recurrence or distant metastases during the follow-up period was recorded and considered as an end point for follow-up.

Eligibility criteria:
inclusion criteria: * all operable female patients affected with multifocal breast cancer exclusion criteria: * inflammatory breast cancer * patients need receiving neoadjuvant therapy

Keywords: breast conservative surgery oncoplastic breast surgery
effect of exobdnf lactic acid bacteria supplement on cognitive functions, sleep and psychological

Conditions: Cognitive Functions Perceptual Disturbances; Cognitive Function Abnormal; Sleep; Psychological

Summary: this open-label, single-group, pre/post-test clinical study was conducted to investigate whether exobdnf probiotic supplementation could improve cognitive ability. it is expected that 40 subjects aged 18 years and above will be recruited, with a target of 30 cases, to take exobdnf probiotics for a total of 8 weeks.

pre-test and post-test were conducted at week 0 and week 9, respectively. the test items included cognitive test battery, scd-q subjective cognitive decline questionnaire, tcq cognitive function scale, mmse mini-mental scale, moca montreal cognitive assessment scale, psqi pittsburgh sleep quality scale and dass-21 depression, anxiety and stress scale, as well as blood biochemical examination and fecal intestinal flora analysis. the subjects were asked to take a capsule containing 1 x 1010 cfu of exobdnf probiotics once daily. subjects are required to maintain a regular lifestyle. after starting the diet, subjects filled out a daily diary that included questions about study product intake, other food intake, bowel movement frequency, stool quality (consistency and color), any medications received, and any unpleasant symptoms such as diarrhea, constipation, vomiting, flatulence, and discomfort. it is expected that this project will help clarify whether supplementation with pediococcus acidilactici exobdnf can help improve cognitive ability, sleep or mental health.

Eligibility criteria:
inclusion criteria: 1. subjects must be volunteers who are 18 years of age or older, mentally clear and able to communicate. 2. subjects who agree to participate in this trial and voluntarily sign the trial consent form. exclusion criteria: 1. subjects who are expected to be or have been confirmed to be pregnant (medical history). 2. subjects with gallbladder disease, gastrointestinal disease, gout, porphyria, or a history of gastric weight control surgery. 3. subjects with high blood pressure (≥160/100 mmhg after resting for 10 minutes) or taking diuretics. 4. subjects with heart disease, hepatorenal insufficiency, hyperthyroidism or hypothyroidism, cushing's syndrome, malignant tumors, or any other disease that may affect the results of the study. 5. subjects with severe hearing or visual impairment that makes it impossible to perform examinations and assessments. 6. subjects with any history of brain surgery, penetrating, neurovascular, infectious or other severe brain injury, epilepsy or other major neurological abnormalities, such as traumatic brain injury with loss of consciousness for more than 24 hours, or memory loss after head trauma for more than 7 days were excluded. 7. subjects with intellectual disabilities. 8. subjects who had consumed probiotics or were expected to consume probiotics within 2 weeks before the screening visit. 9. subjects who had participated in or were expected to participate in clinical trials within 4 weeks before the screening visit.

Keywords: probiotics exobdnf cognitive functions
biological effects of treatment with resveratrol in art patients

Conditions: Infertility, Female

Summary: to evaluate the effects of a new nutraceutical formulation containing resveratrol (trademark genante) on gamete quality in order to improve the reproductive process during art.

the purpose of the study is to evaluate the effect of a new nutraceutical formulation containing resveratrol (trademark genante) on gamete quality in order to improve the reproductive protocols during assisted reproductive technology (art) protocols. the study is a randomized, single blind, parallel, comparative, experimental study during the pre-treatment before in vitro fertilization-embryo transfer (ivf-et). a total number of 100 patients will be enrolled: 50 patients with a pretreatment control group (control group) and 50 patients with experimental pretreatment study group (resveratrol group). patients will be assigned to groups during the recruitment phase in a randomized manner. in the control group, the treatment will consist of taking 400 microg once a day of folic acid commonly suggested as part of clinical practice, while in the resveratrol group, patients will receive one tablet twice a day (two tablets/day) of genante. it is specified that the pretreatment with genante includes folic acid in accordance with the clinical practice, 400 total microg per day. both treatments will last for 3 months before the ivf procedure.

Eligibility criteria:
inclusion criteria: * women with a diagnosis of infertility * bmi between 18 and 30 kg/m2, * regular uterine cavity * normal thyroid function * normal blood parameters exclusion criteria: * primary or secondary ovarian failure * patients who adhered to bologna criteria (at least two of the following: advanced maternal age \>40, less than 3 oocytes recovered in previous attempts, abnormal ovarian reserve test) * presence of ovaries inaccessible to the oocyte pick-up, * persistent ovarian cysts \> 20 mm, * presence of sactosalpinx * heterologous fertilization, significant systemic disease or other situations unsuitable for ovarian stimulation
vitamin d level and its relation to pre-eclampsia and eclampsia

Conditions: Vitamin D Deficiency; Pre-Eclampsia; Eclampsia, Antepartum

Summary: to compare 25(oh)d level in patients with pre-eclampsia, eclampsia and normotensive pregnant women as well as to study the prevalence of vitamin d deficiency among the 3 groups.

200 patients with pre-eclampsia, 100 with eclampsia and 200 normotensive pregnant controls attending delivery/emergency department in kasr al ainy hospital will be included in the study (from march 2019 till september 2019). 25(oh) d level will be measured for the three groups. * preeclampsia is defined as systolic bp \>140 and/or diastolic bp\>90 on two occasions, 4 hours apart in pregnant females\>20 weeks, plus proteinuria \>/= 1+ urine dipstick protein. * eclampsia defined as tonic-clonic seizures in women with pre-eclampsia. * controls are normotensive pregnant females with no proteinuria and no other medical disorders. * the determination of 25(oh) d is based on a competitive enzyme-linked immunosorbant assay (elisa) using the 25(oh)d3/d2 elisa system (orgentic diagnostika gmbh, germany) inclusion criteria: age 20-35 years gestational age 30-40 weeks exclsion criteria: twin pregnancy other medical conditions during prrgnancy drugs that influence vit d levels eg.antiepileptics and antituberculous treatment.

Eligibility criteria:
inclusion criteria: * age 20-35 years * gestational age 30-40 weeks exclusion criteria: * twin pregnancy * other medical conditions during pregnancy * drugs that influence vit d levels eg.antiepileptics and antituberculous treatment
nab-paclitaxel in combination with pyrotinib in postoperative adjuvant therapy for her2-positive breast cancer

Conditions: Early Breast Cancer

Summary: this is a multicenter, open-label, single-arm, prospective, phase ii study. conducted to evaluate the efficacy, safety and tolerability of nab-paclitaxel plus pyrotinib in patients with lymph node-negative and tumor size ≤3 cm, her2 positive breast cancer.


Eligibility criteria:
inclusion criteria: * enrollment subjects must have a pathological diagnosis of her2-positive primary invasive breast cancer with an immunohistochemistry (ihc) score of 3 +, or 2 + and her2 gene amplification by in situ hybridization (ish) (ratio of her2/cep17 ≥ 2.0). * the invasive tumor had to measure no more than 3cm and with histologically confirmed lymph node-negative or one lymph node micrometastasis (t ≤ 3 cm, n0/n1mi, m0). * tumor should has known er/pr hormone receptor status. * all patients must be women above18 years old with eastern cooperative oncology group score 0 to 1. * adequate hematopoietic function and organ function as defined as follows: neutrophil count ≥ 1.5 x 109/l; platelet count ≥ 90 × 109/l; hemoglobin ≥ 90 g/l; total bilirubin ≤ 1.5 × uln; alanine transaminase (alt) and aspartate transaminase (ast) ≤ 3 × uln; serum creatinine cr ≤ 1.5 × uln and creatinine clearance ≥ 50 ml/min (cockcroft-gault formula). * left ventricular ejection fraction (lvef) ≥ 50% and electrocardiogram fridericia-corrected qt interval (qtcf) ≤ 480 ms. * provide written informed consent. exclusion criteria: * clinical or radiologic evidence of local or regional recurrence of disease or metastatic disease prior to or at the time of study entry. * previous treatment with chemotherapeutic drugs, or tyrosine kinase inhibitors targeting her2 (lapatinib, neratinib or pyrotinib, etc.). * other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma. * inability to swallow, chronic diarrhea, or intestinal obstruction. * known to be allergic to the drug components. * have a history of immunodeficiency, including hiv positive, hcv positive, active viral hepatitis b or other immunodeficiency diseases. * have a history of organ transplantation. * pregnant, lactating female patients, or female patients who are unwilling to take effective contraceptive. * any heart disease, including: (1) arrhythmia; (2) myocardial infarction; (3) heart failure. * any other concomitant diseases assessed by investigator as unsuitable for study. * previous history of definite neurological or psychiatric disorders. * concomitant use of cyp3a4 inhibitors or inducers or drugs that prolong the qt interval.
clinical effect and safety of pdt and rfa for unresectable ehcc

Conditions: Cholangiocarcinoma

Summary: the prognosis of patients with advanced unresectable ehcc is very poor with a median survival of 3 to 6 months. active control of tumor growth is the key to extending stent patency and survival for patients with unresectable locally advanced ehcc. photodynamic therapy (pdt) is by far the only modality that has shown to improve stent patency as well as over survival (os) in patients with cholangiocarcinoma. in recent years, many studies have shown that endoscopic radiofrequency ablation (rfa) extends stent patency and possibly the survival of patients with malignant biliary obstruction. however, there are few reports comparing the clinical efficacy and advers event of these two endoscopic treatment.

extrahepatic cholangiocarcinoma (ehcc) originates from the hepatic hilar region to the lower common bile duct. the prognosis of patients with advanced unresectable ehcc is very poor with a median survival of 3 to 6 months. active control of tumor growth is the key to extending stent patency and survival for patients with unresectable locally advanced ehcc. photodynamic therapy (pdt) is by far the only modality that has shown to improve stent patency as well as over survival (os) in patients with cholangiocarcinoma. in an attempt to improve stent patency placed for malignant biliary obstruction, enthusiasm for endoscopic retrograde cholangio-pancreatography (ercp)-guided radiofrequency ablation (rfa) has been increasing in recent years. the habibtm endohbp catheter is an endoscopic bipolar rfa catheter with proven safety and effectiveness for biliary rfa of cholangiocarcinoma. many studies have shown that endoscopic rfa extends stent patency and possibly the survival of patients with malignant biliary obstruction. however, there are few reports comparing the clinical efficacy and advers event of these two endoscopic treatment.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed cholangiocarcinoma; * unresectable cholangiocarcinoma due to local infiltration of major vessels according to computed tomography (ct), magnetic resonance cholangiopancreatography (mrcp), or endoscopic ultrasound（eus）; * no previous treatment; * adequate bone marrow and organ function (white blood cells\>4.0×109/l, hemoglobin\>90 g/l, and platelets\>75×109/l, serum creatinine\<2.0 mg/dl); * a karnofsky performance status (kps) score ≥ 50; * signed written informed consent. exclusion criteria: * imaging examination (ct, mrcp, eus) showed distant metastasis of liver, lung and other organs; * coexistent with other malignant tumors; * pregnant or nursing women; * previous gastrointestinal diversion; * participation in another study during the month before enrollment in this study; * alcohol and/or substance abuse or potentially poor compliance per a doctor's judgment.

Keywords: extrahepatic cholangiocarcinoma photodynamic therapy radiofrequency ablation
implications of a paediatrician-psychologist tandem for sickle cell disease care and impact on cognitive functioning

Conditions: Sickle Cell Disease

Summary: sickle cell disease (scd) necessitates a paediatric treatment plan that considers the influence of psychological, family and intercultural factors. at the louis-mourier hospital (aphp) in colombes, france, a paediatric-psychological partnership where a clinical psychologist accompanies the paediatrician at programmed consultations was introduced. the psychological repercussions of scd were assessed among children and their parents treated in colombes and in two other paediatric units without a paediatric-psychological partnership.


Eligibility criteria:
inclusion criteria: * children under 18 years old * major form of scd (ss, sc, sβ° thal, sβ+ thal) diagnosed by electrophoresis exclusion criteria: * child or parent residing in france less than 6 months * having received scd treatment in more than one centre

Keywords: paediatric-psychological partnership child mental health integrated care well-being
anti-e1e2 antibodies (d32.10 epitope-binding antibodies) and hcv triple therapy

Conditions: Hepatitis C

Summary: the hypothesis was to check whether baseline anti-e1e2 antibodies were correlated with the on-treatment viral kinetics and could predict virological outcome in treatment-experienced hcv-infected cirrhotic patients receiving protease inhibitor-based triple therapy.


Eligibility criteria:
inclusion criteria: * hcv patients with compensated cirrhosis (child-pugh a) * hcv genotype 1 * non-responders to a previous course of interferon (ifn)/ribavirin * receiving boceprevir or telaprevir exclusion criteria: -

Keywords: hepatitis c anti-e1e2 antibodies cirrhosis triple therapy
a study of tocilizumab and methotrexate treatment strategies (adding tocilizumab to methotrexate versus switching to tocilizumab) in patients with active rheumatoid arthritis with inadequate response to prior methotrexate treatment

Conditions: Rheumatoid Arthritis

Summary: this 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv every 4 weeks + placebo po weekly. after the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. the anticipated time on study treatment is up to 3 years, and the target sample size is approximately 470 patients.


Eligibility criteria:
inclusion criteria: * adult patients, ≥ 18 years of age; * moderate to severe active rheumatoid arthritis (disease activity score (das28) \> 4.4); * inadequate response to methotrexate; * on a stable dose of ≥ 15mg/week methotrexate for at least 6 weeks. exclusion criteria: * prior treatment with a biologic; * rheumatoid arthritis (ra) functional class iv; * known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections; * evidence of active malignant disease.
the value of artificial intelligence-based 18f-fdg pet/ct in diferential diagnosis, efficacy prediction and prognosis prediction of t-nk cell lymphoma: a clinical study

Conditions: T-NK Cell Lymphoma

Summary: based on the pet/ct imaging data of patients with t-nk cell lymphoma, machine learning and deep learning methods are used to extract imaging features, establish a t-nk cell lymphoma prediction model, and provide more scientific and accurate prognosis prediction for the clinic.

this study adopts a multicenter retrospective cohort study design，we provided pet/ct of 200 patients with t-nk cell lymphoma as an external validation set for model validation.

Eligibility criteria:
inclusion criteria: 1. pathological histology confirmed as t-nk cell lymphoma; 2.18f-fdg pet/ct examination before treatment; 3. using modern best practice treatment options; 4. complete clinicopathological and follow-up data were obtained. exclusion criteria: 1. the patient had previously received antitumor therapy; 2. the patient had a history of other tumors; 3. incomplete clinical information or imaging data; 4. concomitant other malignant tumors.

Keywords: t-nk cell lymphoma pet/ct diferential diagnosis efficacy prediction prognosis prediction
safety study of a single dose of regn88(sar153191)in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study will test the safety and tolerability (how the body reacts to the drug) of regn88 and placebo (an inactive substance that contains no medicine) in patients with rheumatoid arthritis.

this is a multi-center, randomized, double blind, placebo-controlled, single dose escalation study of the safety and tolerability of subcutaneously administered regn88 in rheumatoid arthritis patients who are receiving concomitant methotrexate. three (3) sequential dose cohorts of 5 subjects (4:1 active: placebo) will be dosed sc with regn88 or placebo. subjects who complete the study will participate in 14 study visits over 16 weeks.

Eligibility criteria:
inclusion criteria: 1. male or female ≥ 18 years of age 2. subjects must weigh \> 50 kg and \< 100 kg 3. diagnosis of rheumatoid arthritis (ra) as defined by the 1987 revised american college of rheumatology (acr) criteria with disease duration of no less than 6 months and acr class i-iii 4. for women of childbearing potential, a negative serum pregnancy test at the screening visit (visit 1) and a negative urine pregnancy test at day -1 5. for men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner\[s\] become pregnant) during the full course of the study. exclusion criteria: 1. a history of listeriosis or active tuberculosis (tb) 2. persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit 3. history of prior articular or prosthetic joint infection 4. history of a hypersensitivity reaction, other than localized injection site reaction (isr), to any biological molecule 5. significant concomitant illness such as, but not limited to cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the subject's participation in this study 6. received administration of any live (attenuated) vaccine within 3 months prior to the screening visit

Keywords: ra